Owl Rexall Drug

GUDID 10822383295463

Owl Rexall Drug, Sportneb

Drive Devilbiss Healthcare

Nebulizing system, non-heated

• Primary Device ID: 10822383295463
• NIH Device Record Key: c0b6854a-1846-4ddd-99db-4e13c7e8e380
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Owl Rexall Drug
• Version Model Number: 3050-2-OWLPN
• Company DUNS: 867673159
• Company Name: Drive Devilbiss Healthcare
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00822383295466 [Primary]
GS1	10822383295463 [Package]; Contains: 00822383295466; Package: [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K003344

FDA Product Code

• BTI: Compressor, air, portable

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-16

On-Brand Devices [Owl Rexall Drug]

• 10822383511358: OWLPacificaEliteNebW/reusenk, 6/RTL/CS
• 10822383295463: Owl Rexall Drug, Sportneb